NCT06022991

Brief Summary

AIMS: The primary aim is to investigate the impact of enhancing father/partner engagement in FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge. Secondary aims are to investigate the impact on maternal MH. METHOD and ANALYSIS: This is a two-phase study: Phase-1 to gather baseline information and Phase-2 to assess the impact of improved father/partner engagement in FICare involving two NUs (a tertiary and level 2). 20 families of infants born at \<33 weeks will be studied in each phase (40 fathers, 40 mothers, 40 babies). Father/partner MH will be assessed using validated questionnaires: Generalised Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale: NICU (PSS:NICU), and by semi-structured qualitative interviews. Similarly, mothers will be assessed by the same questionnaires and focus groups. The Neonatal DadPad materials will be updated using information from phase 1 study, systematic review of Fathers experiences of FICare and advice from parent advisory group. Father's engagement in FICare will be enhanced using Neonatal DadPad information booklet and app, father-specific peer support and bitesize teaching on caring for NU babies (Phase 2). Thematic analysis of the qualitative data will be performed. Phase 1 and Phase 2 study findings will be compared by performing appropriate statistical analysis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Nov 2022Oct 2026

First Submitted

Initial submission to the registry

July 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

3.9 years

First QC Date

July 27, 2022

Last Update Submit

September 1, 2023

Conditions

Mental Health Wellness 1Premature Birth

Keywords

Father/partner wellbeingMaternal wellbeingPaternal infant engagementNICUFamily integrated care (FICare)

Outcome Measures

Primary Outcomes (1)

  • Paternal mental health

    Fathers' mental stress is assessed by semi-structured interviews.

    From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeks

Secondary Outcomes (6)

  • Fathers care giving ability

    From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge

  • Parental enagement

    6 weeks post baby discharge from Neonatal Unit

  • Maternal mental health

    From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge

  • Paternal mental health

    From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge

  • Paternal anxiety

    From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Babies born between 22+0 and 32+6 weeks who have two main caregivers

You may qualify if:

  • Parents of 22+0 to 32+6 weeks preterm infants.
  • Infant from day one to 7 days of age.
  • Infant should have two primary caregivers. Father's/Partner's participation in the study is a must and participation from both parents is ideal.
  • The parents should have conversational English.

You may not qualify if:

  • Infant with life-limiting condition or no realistic chance of survival.
  • Infant is likely to be transferred to non-participating centre within 4 weeks of age.
  • Parents under the age of 16 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neonatal Unit, Whipps Cross University Hospital

London, E11 1NR, United Kingdom

RECRUITING

Neonatal Unit, Homerton University Hospital

London, E9 6SR, United Kingdom

RECRUITING

Related Publications (1)

  • Rubinstein R, Gallagher K, Ho J, Bose J, Khashu M, Aladangady N. Investigating Father or Partner Involvement in Family Integrated Care in Neonatal Units: Protocol for a Prospective, Multicenter, Multiphase Study. JMIR Res Protoc. 2024 Mar 25;13:e53160. doi: 10.2196/53160.

    PMID: 38526549DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Narendra Aladangady, PhD

    Homerton Healthcare NHS Foundation Trust

    STUDY DIRECTOR

Central Study Contacts

Rupa Rubinstein, MRCPCH

CONTACT

02085105555rupa.rubinstein@nhs.net

Narendra Aladangady, PhD

CONTACT

02085105555n.aladangady@nhs.net

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2022

First Posted

September 5, 2023

Study Start

November 1, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Anonymised data only collected

Locations

GB(2)